Understanding UDI requirements: for suppliers
Tuesday 26 June 2018
10:00 AM to 03:00 PM
Hasilwood House, 60 Bishopsgate, London, EC2N 4AW, United Kingdom
Member price: £199.00 per person
Non-Member price: £399.00 per person
Being able to identify, track and trace medical devices at a global level enhances quality of care, patient safety and business processes. This is why the US Food and Drug Administration (US FDA) and new EU regulations now require medical devices and in-vitro diagnostics to carry a barcoded Unique Device Identifier (UDI) - a UDI number is needed on the medical device label, its packaging and, in some cases, the device itself.
With the Department of Health, US FDA and EU mandating the use of our standards, it's now critical that these are correctly adopted throughout the healthcare supply chain.
This interactive course will provide the foundations you need for implementation.
This course is aimed at any medical device manufacturer trading in the US or Europe. Implementation of UDI regulations will require input from a cross-functional team, so this course is recommended for staff from the following departments:
- Pack/label design
- Quality assurance
- Supply chain
- How the GS1 System is improving healthcare supply chains
- How manufacturers can use GS1 standards to meet global UDI requirements
- The potential of GS1 standards to cut costs and save lives
- How GS1 standards are used to automate a variety of use cases, including recalls and inventory management
- The next steps for GS1 implementation
- GS1 and global healthcare regulations
- Timescales for compliance
- Identifying different packaging levels
- Encoding production information
- Barcode best practice
- Barcode/label sample review
- Data requirements
- Post-course support
If you have a number of staff for whom this course would be useful, or if travelling to London is too difficult, contact us to arrange delivery of this course onsite.
Please contact Ben Clarke on 020 7092 3541 or email firstname.lastname@example.org if we can be of any further assistance.
Hasilwood House, 60 Bishopsgate
London, EC2N 4AW